NCT02578979

Serial ECG Versus Holter to Detect Atrial Fibrillation in Elderly Ischemic Stroke Patients

Completed NA Last updated 8 July 2019

What this trial tests

NA trial testing Electrocardiogram in Ischemic Stroke in 826 participants. Completed in 31 October 2018.

Timeline

1 October 2015

Primary endpoint
31 July 2018

31 October 2018

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	826
Start date	1 October 2015
Primary completion	31 July 2018
Estimated completion	31 October 2018
Sites	6 locations across Taiwan

Drugs / interventions tested

• Electrocardiogram
• Holter

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Chang Gung Memorial Hospital

Who can join

65 and older, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Paroxysmal atrial fibrillation is often undetected because characteristics such as short duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional 24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However, systematic review suggests Holter monitoring will identify atrial fibrillation in only an additional 4.6% of patients, no better than detection rates observed in groups lacking routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond repeated 12-lead ECGs is made in the United Kingdom guideline. Serial 12-lead ECG has been used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%) without atrial fibrillation at baseline. The optimal investigation strategy, including modality, duration of investigation, and patient subgroup remains undefined, not only for efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare systems. The objective of this project is to conduct a pragmatic multicenter randomized controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without atrial fibrillation identified by baseline ECG or history.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events: A randomized clinical trial.
   Huang WY, Lee M, Sung SF, Tang SC, et al · · 2021 · cited 5× · PMID 32640882 · DOI 10.1177/1747493020938297
2. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events (AFTER-PULSE): Study protocol for a randomized controlled trial.
   Hsieh TT, Lee M, Huang WY, Tang SC, et al · · 2017 · cited 3× · PMID 29082335 · DOI 10.1016/j.conctc.2017.04.005